Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals

Dry Eye Disease Clinical Trial

Official title:

Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443554
• Other study ID #: 2023ks-61-1
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Fujian University of Traditional Chinese Medicine
• Contact: Zhang Shiyan
• Phone: 15159718855
• Email: 2020011012006[@]stu.hznu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effectiveness of a community health management program for middle-aged and elderly patients with dry eye disease (DED). By comparing the community-based health management plan with conventional treatment, the study aims to determine the impact on eye health and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Patients meeting the diagnostic criteria for dry eye disease.

2. Middle-aged and elderly individuals aged 45 years and above.

3. Normal cognitive and expressive abilities.

4. Informed consent and ability to complete the survey.

5. Voluntary participation in the study.

Exclusion Criteria:

1. Patients with other ocular surface diseases, including stye, trachoma, allergic conjunctivitis, etc.

2. Patients with severe cataracts, glaucoma, uveitis, retinal detachment, optic nerve diseases, high myopia, or other conditions.

3. Patients who have undergone eye surgery or have a history of eye trauma in the past three months.

4. Patients who did not sign the informed consent form.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Procedure:
• Health Management Intervention Program
This study implemented a 12-week eye health management intervention program based on the Protection Motivation Theory (PMT). The intervention included eye health interventions conducted twice weekly at community health service locations.During the health management process, specialist doctors from higher-level comprehensive hospitals provided professional guidance, while community general practitioners took on a leading role. They provided personalized eye health management for patients under the guidance of the PMT theory. The intervention content included group education, individual guidance, experience sharing meetings, and traditional Chinese medicine appropriate technology, among other aspects.
• Standard Treatment
Each week, patients were subjected to standard treatment and follow-up procedures, including basic interventions, medication, and routine follow-up via phone or WeChat, during which general conditions were assessed.

Locations

Country	Name	City	State
China	The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goal Attainment Scaling (GAS)	GAS is an individualized assessment method encompassing multiple personal goals, with a standardized formula for calculating total scores to facilitate comparisons. A score of 50 represents the expected level of achievement, with higher scores indicating greater goal attainment. GAS demonstrates good reliability, validity, and sensitivity. Based on the GAS goal list, researchers and participants collaboratively select goals and assign weights. Expected goals (assigned 0 points) and other goal levels (significantly above expected +2, slightly above expected +1, slightly below expected -1, significantly below expected -2) are established. Goal attainment is evaluated during follow-up, and GAS scores are calculated.	12 weeks
Primary	Ocular Surface Disease Index (OSDI)	The OSDI questionnaire assesses common dry eye symptoms and their frequency, aiding in the grading of dry eye severity. It focuses on symptoms such as dryness, foreign body sensation, stinging, photophobia, blurred vision, and the impact on daily life and environmental factors. Symptoms are rated on a scale of frequency: always (4 points), most of the time (3 points), half of the time (2 points), occasionally (1 point), and never (0 points). The OSDI total score is calculated as (sum of item scores × 25)/12, ranging from 0 to 100, with higher scores indicating more severe symptoms.	12 weeks
Primary	Schirmer I Test	The Schirmer I test measures tear secretion by placing a Schirmer strip under the lower eyelid conjunctiva with the patient's eyes closed, measuring tear absorption over 5 minutes. This test is widely used to evaluate dry eye syndrome. Tear secretion measured by Schirmer I test (without anesthesia) >5 mm/5 min and =10 mm/5 min indicates mild dry eye; >3 mm/5 min and =5 mm/5 min indicates moderate dry eye; and =3 mm/5 min indicates severe dry eye.	12 weeks
Primary	Quality of Life for Dry Eye Patients	NEI-VFQ-25:This is one of the most commonly used ophthalmic quality of life questionnaires, assessing vision-related issues and patients' quality of life. It consists of 25 questions divided into three parts: general health and vision, limitations in activities, and responses to vision problems. The items are categorized into dimensions such as overall health, overall vision, eye pain, near activities, distance activities, peripheral vision, color vision, driving, social functioning, role limitations, dependency, and mental health. Respondents rate their subjective experience on a 5 or 6-point scale, with scores weighted according to the question type, using values such as 100, 75, 50, 25, 0, or not scored. The highest possible score is 100, and the lowest is 0. Scores for each dimension are averaged, and overall scores for each section are averaged from the dimension scores. Higher scores indicate better quality of life.; 8.Diagnostic Criteria for Dry eye disease (DED).	12 weeks